Actively Recruiting

Age: 18Years +
FEMALE
Healthy Volunteers
NCT06021769

Pessary Experience Study

Led by University of Virginia · Updated on 2025-01-28

30

Participants Needed

1

Research Sites

181 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Pessaries are silicone devices inserted into the vagina for treatment of pelvic organ prolapse or stress urinary incontinence. They are adequate treatment options for patients who are poor surgical candidates, those who decline surgical intervention, or as a temporizing measure in those ultimately planning surgery. Most studies suggest that about 75% of patients are able to be successfully fit with a pessary, but about 50% discontinue pessary use within 12 months of initiation. The purpose of this study is to determine why pessaries are discontinued.

CONDITIONS

Official Title

Pessary Experience Study

Who Can Participate

Age: 18Years +
FEMALE
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • English-speaking women aged 18 years or older
  • Choosing to undergo a pessary fitting for symptomatic pelvic organ prolapse and/or stress urinary incontinence at the University of Virginia Pelvic Medicine and Reconstructive Surgery clinic
  • Willingness and ability to comply with scheduled visits and study procedures
  • Successful pessary fitting
Not Eligible

You will not qualify if you...

  • Pregnant women
  • Prisoners
  • Cognitively impaired individuals
  • Non-English speaking subjects
  • Patients unable to comply with pessary check visits
  • Active vaginal infection
  • Vaginal malignancy
  • Genitourinary tract fistula

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

University of Virginia

Charlottesville, Virginia, United States, 22903

Actively Recruiting

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Research Team

M

Monique Vaughan, MD

CONTACT

M

Monique Vaughan, MD

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

1

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